This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Principal Investigator of the Program, Dr. Jos[unreadable] R. Carlo-Izquierdo, Chancellor of the Medical Sciences Campus, has the responsibility of ensuring that program goals are met and that appropriate institutional support is provided to the program. All responsibilities of daily operations are delegated to the Program Director. The RCRII Program has a Director, an Associate Director, and an Assistant Director. The combined percentage of their effort provides 100% of a full time position. The Program Director, Dr. Julio E. Benabe, has a 40% time effort and oversees the entire program. He presides a weekly staff meeting where all issues concerning the daily activities of the RCRII are reviewed and discussed with the entire staff. The PD also attends the monthly meeting with the RCAC and reports to them the important issues related to new studies, development of established collaborations, and the links with the participating programs supported by the RCRII. As the Associate Chief of Staff for R&D at the VA Hospital, it is not possible for Dr. Benabe to be physically present in the unit at all times, however, the Associate Director, Dr. Carlos Luciano (35%), and the Assistant Director, Dr. Marcia Cruz (25%), allow for a constant presence of one of the Directors and assist the P.D. in all aspects of the operation of the program. The Associate Program Director serves as a liaison with the faculty and administrative mechanisms in the Medical Sciences Campus, facilitating the implementation of the program's goals and specific aims within the institution. The Research Clinical Advisory Committee (RCAC) has an instrumental role in the directorship of the RCRII. The RCAC is composed of two subcommittees, an internal subcommittee composed of faculty and investigators from the UPR-MSC and an External Subcommittee composed of our external advisors Drs. Brater, Watkins, and Palefsky. The RCAC is responsible for approving all the protocols conducted at the RCRII, for the process of selection of the pilot projects, for the allocation of RCRII resources, and for overseeing the operation and the policies of the RCRII. It also provides advice to the P.I. and the PDs on scientific initiatives. The Internal Subcommittee of the RCAC meets on a monthly basis to review submitted protocols and the general direction of the RCRII. The committee evaluates each protocol using a standard format developed and approved by the committee to address all the relevant issues pertaining protocols at the RCRII. Each protocol is reviewed by two "primary" reviewers who are voting members of the committee and then are considered by the committee as a whole. Additional input from the biostatistician and the RSA is requested. The PD, Associate PD, and Assistant PD attend each of the RCAC monthly meetings as non-voting members. They discuss all matters pertaining to the daily activities at the RCRII, compliance with all the regulations to conduct clinical research in a federally funded program, review data and safety monitoring plans for all new protocols, and participate in the discussion and assessment of all new protocols applying for use of the RCRII facilities as well as in the proposed collaborations with other programs.